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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Cantor Fitzgerald
Merck
Colorcon
Boehringer Ingelheim
Chinese Patent Office
Deloitte
Covington
Queensland Health

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065419

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NDA 065419 describes AZITHROMYCIN, which is a drug marketed by Epic Pharma Llc, Lupin Ltd, Pliva, Sandoz, Teva Pharms, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Mylan Asi, Mylan Labs Ltd, Sun Pharm Inds Ltd, Teva Parenteral, Apotex Corp, Mylan, Teva, and Wockhardt, and is included in thirty-six NDAs. It is available from fifty-two suppliers. Additional details are available on the AZITHROMYCIN profile page.

The generic ingredient in AZITHROMYCIN is azithromycin. There are thirty-two drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the azithromycin profile page.
Summary for 065419
Tradename:AZITHROMYCIN
Applicant:Teva Pharms
Ingredient:azithromycin
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065419
Ingredient-typeMacrolides
Medical Subject Heading (MeSH) Categories for 065419
Suppliers and Packaging for NDA: 065419
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065419 ANDA Teva Pharmaceuticals USA, Inc. 0093-7148 N 0093-7148-23
AZITHROMYCIN azithromycin FOR SUSPENSION;ORAL 065419 ANDA Teva Pharmaceuticals USA, Inc. 0093-7149 N 0093-7149-23

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 100MG BASE/5ML
Approval Date:Jun 24, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 200MG BASE/5ML
Approval Date:Jun 24, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Julphar
Express Scripts
Fuji
Cipla
QuintilesIMS
Covington
Deloitte
Teva

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